NCT02112071已完成不适用
Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- endothelial function measured by brachial artery flow mediated vasodilation
研究概览
简要总结
The general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• An individual must be >18 years of age
- •Have diagnosed type 2 diabetic mellitus by one of the following criteria:
- •o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year).
- •If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be >25kg/m2 at the time of diagnosis.
- •Diagnosed kidney attributed to diabetes by one of the following criteria:3
- •Macroalbuminuria (ACR >300mg/g, or)
- •Microalbuminuria (ACR between 30-300 mg/g) or in the presence of diabetic retinopathy (although is recognized that about 1/3 of type 2 diabetics do not have retinopathy by fundoscopic exam).
- •An elevated ACR should have been confirmed in the absence of urinary tract infections with 2 additional first-void specimens collected over 3-6 months.
- •At least 2 of 3 samples should fall within the range of micro or macroalbuminuria.
- •An estimated Glomerular filtration rate (GFR) of between 90 ml/min and 30 ml/min measured by (GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units).
- •Individuals must be able to provide informed consent
- •Perform walking exercise testing on a treadmill
- •Be able to participate in a 12-week supervised exercise program.
排除标准
- •• Patients are currently exercising
- •Requiring dialysis
- •Have an Hematocrit <30%
- •Uncontrolled hypertension (>200/100mmHg)
- •Peripheral vascular disease.
- •An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease., or having undergone a coronary revascularization within the past 6 months prior to enrollment.
结局指标
主要结局
endothelial function measured by brachial artery flow mediated vasodilation
时间窗: at week 0 and at week 12
Endothelium-mediated change in in vascular tone
次要结局
- arterial stiffness measured by pulse wave velocity(at week 0 and at week 12)
- Circulating markers of vascular health(at week 0 and at week 12)
- 24-hour albuminuria(at week 0 and at week 12)
- aerobic capacity(at week 0 and at week 12)
- blood pressure(at week 0 and at week 12)
研究者
研究点 (2)
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